International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatrogenic or Spontaneous Esophageal Perforation.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Leakage After Esophagectomy
- Sponsor
- Aesculap AG
- Enrollment
- 108
- Locations
- 17
- Primary Endpoint
- Healing rate of the esophageal anastomosis leakage or esophageal perforation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.
Detailed Description
Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician. Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE® therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE®. Eso-SPONGE® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients. The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
- •age \> 18 years
- •written informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Healing rate of the esophageal anastomosis leakage or esophageal perforation
Time Frame: until day of discharge (approximately 2 weeks)
Reduction of the cavity, endoscopic vacuum therapy no longer necessary
Secondary Outcomes
- Number of Eso-SPONGE® changes(until day of discharge (approximately 2 weeks))
- Total number of sponges used(until day of discharge (approximately 2 weeks))
- Average replacement intervals(until day of discharge (approximately 2 weeks))
- Duration of endoscopic vacuum therapy(until day of discharge (approximately 2 weeks))
- Complication Rate(until day of discharge (approximately 2 weeks))